Will your implants give you cancer?

A recent article in the media has created concern for patients regarding a form of cancer related to breast implants. The article was brief, and did not include important information that provides perspective to the risks patients with breast implants face. Hopefully this blog will be helpful

What is BIA-ALCL?

Lymphomas are cancers that originate from a specific type of white blood cell (infection fighting cells in our body, more specifically B cells and T cells), and about 70,000 cases are diagnosed every year in the United States. Anaplastic Large Cell Lymphoma (ALCL) is a specific type of Non-Hodgkin’s T cell lymphoma that makes up a very small percentage of these cases (around 3%). There are two very different types of ALCL. One type occurs on the skin (pcALA), and it has a very good survival rate with many even resolving spontaneously, and treatment may include just watching, excision, or superficial radiation. There is another type of more aggressive systemic ALCL that has an aggressive nature and poorer prognosis. It can present as a mass in lymph nodes and organs including the breast. This type has a 5-year survival rate of 40-60% and requires chemotherapy or possible stem cell transplant.

In the mid 1990s the first case of ALCL occurring around a breast implant was reported, and more recently (for about the last 10+ years) there has been tremendous effort to identify cases and collect data so that this rare form of cancer can be better understood. These specific cases are now referred to as Breast Implant Associated- Anaplastic Large Cell Lymphoma or BIA-ALCL.

To date there have been 375 cases reported (with 258 confirmed) and 9 deaths based on over 20 years of data collected worldwide. Because so many of the cases were in the past, accurate information regarding patients details, implant details, treatment, and follow-up are not complete. A specific database has now been created to track cases as accurately as possible so that more can be learned about how to best treat these patients.

What we do know so far is that BIA-ALCL more closely resembles the milder skin type (pcALCL) and the prognosis is excellent. The 9 patients who have died presented with more extensive disease (masses or distant spread) and may not have been treated appropriately due to misdiagnosis. They may have had the more aggressive form of systemic ALCL, which carries a worse prognosis.

What causes BIA-ALCL?

Chronic inflammation is the precursor to many cancers, and this is also true of BIA-ALCL. If inflammation goes on long enough, there can be malignant degeneration of the cells responding to the irritation. For the perfect storm, there needs to be a genetic predisposition (abnormalities at chromosome 2q23 for those super smarty-pants), the presence of unique bacteria growing on the implant and in the capsule (Rolstonia pickettii has been cited which is very rare and has contaminated water supplies including sterile saline and drugs), and irritation from the implant surface.

Reviewing all of the cases reported to date, only about half include specific implant information. When the information was available, there have been patients with both textured and smooth implants presenting with BIA-ALCL, but those with smooth had previous implants prior to their diagnosis were textured. There are also a significantly higher number of cases involving implants with the more aggressively textured surface (Allergan Biocell) as opposed to Mentor Siltex and the least with Sientra True Texture. There have also been cases using implants not available in the U.S.

The correlation with a textured surface does make sense because they have more surface area and can harbor more bacteria. It is interesting that despite this, textured implants have lower capsular contracture rates than smooth implants. Bacteria play a role in capsular contractures too, but it is typically from the bacteria that colonize our skin like Staph epidermidis.

Outside of the U.S. textured implants are used in 90% of cases. In the U.S. smooth walled implants have been more popular because we only more recently had FDA approval of anatomic or tear drop shaped silicone implants, which only come with textured surfaces. There are reasons why one might choose textured, including the very nice anatomic shape, more reliable implant positioning over time (they drop less, and don’t slide laterally like smooth tend too), and lower capsular contracture rates. Most tissue expanders used in breast reconstruction are also textured.

What are the chances of developing BIA-ACLC?

Low. They are really low. Take these numbers into consideration:

There are probably more than 10 million women with breast implants worldwide, and 1.5 million implants are placed every year.

There have only been 375 cases if BIA-ALCL reported worldwide over 20 years (with only 258 confirmed).

ALCL of the breast without implants is estimated at .03 per million person years. That’s the bad kind of systemic ALCL with a poorer prognosis.

ALCL of the breast with implants is estimated at 2.03 per million patient years. It is significantly higher than without implants, but this is the less aggressive kind of ALCL (similar to the type that occurs on the skin) with an excellent prognosis.

The 9 patients with BIA-ALCL who died may have had the bad systemic type that occurs without implants (because that is close to the number in the general population), and just happened to also have implants. They may also have had a worse genetic predisposition. It is not known.

Right now we do not have evidence that the mild type progresses to the more aggressive type. They may be distinctly different types of ALCL.

Just to give you some perspective, there are around 1.7 million cases of breast cancer diagnosed worldwide every year. 40,000 breast cancer patients die every year within the United States alone. Those numbers are staggering compared to 9 patients dying from BIA-ALCL in 20 years worldwide.

One study on Allergan Biocell textured implants estimate that one case of BIA-ALCL will develop out of 50,000 women when followed for 10 years. Other estimates are between 1 in 30,000 to 1 in 100,000. The risk of dying from BIA-ALCL is about 1 in a million.

Your risk of dying in a traffic accident is 1 in 17,000 and about 1 in 11,000 when having a child. The risk of death with cosmetic surgery is 1 in 5,000.

What are the presenting signs of BIA-ALCL?

Most presented with a late seroma or fluid collection around the implant. More rarely, patients presented with a mass (which carries a poor prognosis). Most late seromas are benign, but with increased awareness regarding BIA-ALCL there will likely now be a high suspicion of any that present. Fluid from a seroma should be aspirated and sent for tumor markers (CD30) to help make the diagnosis. Imaging studies and a cancer specialist (oncologist) will also be likely. Some of the cases of BIA-ALCL were incidental findings at surgery when implants were being exchanged for capsular contracture or other reasons. The average time of presentation was around 10 years (ranging from 1 to 40 years).

How is BIA-ALCL treated?

Early on patients were treated more aggressively the same way systemic ALCL is treated. Some patients also received radiation therapy. Now that more is understood about the disease the recommendations are to treat patients with removal of the implant and surrounding scar tissue capsule. It is currently not known if it is okay to immediately replace implants.

What should you do?

Unless you have unexplained swelling of your breast, fluid around your implant, or a breast mass, you should do nothing other than stay well informed. If you have made it this far in the blog, you are certainly well informed!

Those of us who have been around for a while certainly remember all of the fear around silicone implants in the 90’s. There were surgeons who vowed never to use silicone again because of the potential health risk, and now they are by far the most popular implants in the U.S. and worldwide.

My guess is that surgeons have been missing cases of BIA-ALCL over the years before we knew it existed. I would assume that implants were likely replaced in many of these cases. There has not been a rise in the more advanced cases, actually a decline. We pay so much attention to bacterial contamination at the time of surgery now that I suspect that may play a role in the development of future cases. I also have heard they can now better control bacterial contamination for organisms like Rolstonia in sterile saline and drugs that might be used during surgery. There is also promising research on the horizon for new ways to treat bacterial biofilms that affect way more devices than just breast implants. (There have been reports of lymphoma around joint replacements too, but don’t want to scare you too much!) I also expect with increased awareness we will start finding many more cases that have flown under the radar in past years and will learn the specifics about the behavior of this rare disease and appropriate treatment.

What we do know is that BIA-ALCL is very rare, and the prognosis is excellent when the disease is limited to fluid and the surrounding capsule, which is the majority of cases. 98% are considered cured with just implant removal.

Know your breasts and perform self-breast exams routinely. Breast exams by a physician are recommended yearly, and mammography screening every 1-2 years, based on your age and risk for breast cancer as determined by your primary care physician. The FDA recommends MRI screening for implant ruptures every 2-3 years, and with the risk of rupture increasing after 10 years it is certainly after that time that I feel one should be more diligent about this. If you find a mass, experience a noticeable increase in the size of one breast (often with redness) which could be due to a fluid collection called a seroma, or a significant change in shape, you should have an evaluation by your plastic surgeon.